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    Summary
    EudraCT Number:2008-001372-75
    Sponsor's Protocol Code Number:I2B-MC-GACB
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2008-001372-75
    A.3Full title of the trial
    Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2245461 after Multiple Oral Administrations in Healthy Postmenopausal Women
    A.4.1Sponsor's protocol code numberI2B-MC-GACB
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChorus, a Division of Eli Lilly and Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code LY2245461
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY2245461
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Reduce the number of hot flushes for postmenopausal women
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To investigate the safety and tolerability of multiple oral doses of LY2245461 in healthy postmenopausal women.
    E.2.2Secondary objectives of the trial
    • To characterize the pharmacokinetics (PK) of LY2245461 administered as multiple doses given daily for 28 days in healthy postmenopausal women.
    • To characterize the pharmacodynamic (PD) effects of LY224561 administered daily for 28 days in healthy postmenopausal women.
    • To characterize the PK/PD dose and/or exposure response relationships.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Healthy postmenopausal (natural or surgical) women, 12 months without a menstrual period or perimenopausal women 6 months without a menstrual period and FSH >40 IU/L, age 45 to 65 years, inclusive; history of three or more hot flashes per day by self reporting and more than five hot flashes per day by objective monitoring a hot flash frequency of more than five hot flashes per day (24 hours) as indicated by Biolog hot flash event marking (EM) or the hot flash monitor by skin conductance recording (SCR)
    [2] Body mass index between 20 and 32 40 kg/m2, inclusive.
    [3] Blood pressure between 160-90 mmHg (systolic) and 90-50 mmHg (diastolic) and heart rate (sitting) between 50 and 100 beats per minute as determined by the investigator.
    [4] Normal mammogram within one year and normal Pap smear within three years of the baseline visit.
    [5] Willing to make themselves available for the duration of the study, and abide by the research unit policies, procedures and study restrictions.
    [6] Agree not to use any prescription or over-the-counter medications during the study not approved by the study investigator.
    [7] Have given written informed consent approved by Lilly/Chorus and the Ethical Review Board governing the site.
    E.4Principal exclusion criteria
    [8] Thyroid disease, unless well controlled with TSH in normal range, and stable replacement dose for last 3 months.
    [9] History or presence of clinically significant psychiatric, cardiovascular, peripheral vascular occlusive disease, respiratory, hepatic, renal, gastrointestinal, hematological, neurological, rheumatological, or endocrine disorders, including diabetes mellitus that would, in the investigator’s judgement, constitute a risk when taking the study medication or may significantly alter the absorption, metabolism or elimination of drugs.
    [10] Clinically significant lab abnormality (i.e. fasting lipid profile, chemistry, hepatic function tests, TSH, etc) as judged by the investigator.
    [11] Clinically significant abnormality during gynecological exams or trans-vaginal ultrasound, e.g., endometrial or endocervical polyps, any baseline ovarian cyst (except a simple cyst < 20 mm), an endometrial thickness greater or equal to 5 mm.
    [12] Use of any prescription or over-the-counter medication, except thyroid hormone replacement, and certain medications that are applied to the skin, eyes, or nose that the investigator believes will not affect study drug absorption, metabolism or elimination. Standard multi-vitamins are allowed. Tylenol (acetaminophen, paracetamol) is also allowed.
    [13] Vaginal estrogen therapy will not be allowed within 12 weeks of the baseline visit or during the study.
    [14] Use of any medication that may affect hot flashes within 12 weeks of the baseline visit., including estrogen, progestin, androgen, antidepressants, anxiolytics (i.e. benzodiazepines), clonidine, gabapentin, SERMs (i.e. raloxifene, tamoxifen), and aromatase inhibitors.
    [15] Evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies. Evidence of hepatitis C and/or positive hepatitis C antibody. Evidence of hepatitis B and/or positive hepatitis B surface antigen.
    [16] Electrocardiogram reading considered outside the normal limits by the investigator, and relevant for interpretation or indicating cardiac disease including QTc (Bazett) interval >450 msec, aberrant, blocked or impaired propagation, and signs of ischemic heart disease.
    [17] Smoke more than 10 cigarettes or equivalent in nicotine use or nicotine substitutes per day.
    [18] Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
    [19] Have previously completed or withdrawn from this study.
    [20] Regular use of drugs of abuse and/or positive findings on urinary drug screening.
    [21] Subjects who have an average weekly alcohol intake that exceeds 21 units per week or subjects unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits). Subjects must not drink any alcohol for 24 hours before the first dose of study medication and when in the unit.
    [22] Cumulative blood donation of more than 500 mL within the previous 60 days prior to admission.
    [23] Known allergies to LY2245461 or other components of the drug product.
    [24] Failure for any reason to satisfy the investigator for adequate fitness to participate in the study.
    [25] Anyone who can not read and understand the consent form and study instructions.
    [26] Lilly employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
    [27] Subjects with abnormally elevated cancer antigen 125 (CA 125) results.
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety evaluations to include adverse events, vital signs, ECGs, etc. to be summarized using descriptive methodology.
    2. Pharmacokinetic evaluations - parameters to be evaluated descriptively.
    3. Pharmacodynamic evaluations - Hot flush frequency as measured by the Biolog or the patient diary, and the Hot Flash Related Daily Interference Scale.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 52
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-06
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